Publications by authors named "Yangmin Ning"

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Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Kassa Ayalew, Yang-Min Ning, Michelle J Foringer, Susan Leibenhaut, Jenn W Sellers

Ther Innov Regul Sci· January 2023

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Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning

Ther Innov Regul Sci· September 2022

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Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning

Ther Innov Regul Sci· September 2022

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Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Jenn W Sellers, Camelia M Mihaescu, Kassa Ayalew, Phillip D Kronstein, Bei Yu, Yang-Min Ning

Ther Innov Regul Sci· September 2022

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Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy.
Daniel M Girardi, Scot A Niglio, Amir Mortazavi, Rosa Nadal, Primo Lara, Yang-Min Ning

Clin Cancer Res· April 2022

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Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors.
Andrea B Apolo, Rosa Nadal, Daniel M Girardi, Scot A Niglio, Lisa Ley, Yangmin M Ning

J Clin Oncol· November 2020

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Cabozantinib in patients with platinum-refractory metastatic urothelial carcinoma: an open-label, single-centre, phase 2 trial.
Andrea B Apolo, Rosa Nadal, Yusuke Tomita, Nicole N Davarpanah, Lisa M Cordes, Yangmin M Ning

Lancet Oncol· August 2020

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Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.
V Ellen Maher, Laura L Fernandes, Chana Weinstock, Shenghui Tang, Sundeep Agarwal, Yang-Min Ning

J Clin Oncol· October 2019

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FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Daniel L Suzman, Sundeep Agrawal, Yang-Min Ning, V Ellen Maher, Laura L Fernandes

Oncologist· April 2019

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Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.
Yang-Min Ning, V Ellen Maher, Julia A Beaver, Kirsten B Goldberg, Gideon M Blumenthal

Oncologist· February 2018

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FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum-Containing Chemotherapy.
Yang-Min Ning, Daniel Suzman, V Ellen Maher, Lijun Zhang, Shenghui Tang

Oncologist· June 2017

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Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.
Ravi A Madan, Fatima H Karzai, Yang-Min Ning, Bamidele A Adesunloye, Xuan Huang

BJU Int· October 2016

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U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.
Yang-Min Ning, Michael Brave, V Ellen Maher, Lijun Zhang, Shenghui Tang

Oncologist· August 2015

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Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.
Yang-Min Ning, V Ellen Maher

Urol Oncol· March 2015

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Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013.
Michel D Wissing, Paul G Kluetz, Yang-Min Ning, Jonca Bull, Christine Merenda

Cancer· October 2014

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FDA approval summary: vemurafenib for treatment of unresectable or metastatic melanoma with the BRAFV600E mutation.
Geoffrey Kim, Amy E McKee, Yang-Min Ning, Maitreyee Hazarika, Marc Theoret

Clin Cancer Res· October 2014

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Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.
Paul G Kluetz, Yang-Min Ning, V Ellen Maher, Lijun Zhang, Shenghui Tang

Clin Cancer Res· December 2013

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Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary.
Yangmin M Ning, William Pierce, V Ellen Maher, Stella Karuri, Sheng-Hui Tang

Clin Cancer Res· November 2013

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The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention.
Marc R Theoret, Yang-Min Ning, Jenny J Zhang, Robert Justice, Patricia Keegan

N Engl J Med· July 2011

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Targeting the regulation of androgen receptor signaling by the heat shock protein 90 cochaperone FKBP52 in prostate cancer cells.
Johanny Tonos De Leon, Aki Iwai, Clementine Feau, Yenni Garcia, Heather A Balsiger, Yang-Min Ning

Proc Natl Acad Sci U S A· July 2011

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Accelerated approval of oncology products: the food and drug administration experience.
John R Johnson, Yang-Min Ning, Ann Farrell, Robert Justice, Patricia Keegan

J Natl Cancer Inst· April 2011

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Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy.
Wilfred D Stein, James L Gulley, Jeff Schlom, Ravi A Madan, William Dahut, Yang-Min Ning

Clin Cancer Res· February 2011

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Phase II trial of bevacizumab, thalidomide, docetaxel, and prednisone in patients with metastatic castration-resistant prostate cancer.
Yang-Min Ning, James L Gulley, Philip M Arlen, Sukyung Woo, Seth M Steinberg

J Clin Oncol· April 2010

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Reversal of docetaxel resistance with bevacizumab and thalidomide.
Yang-Min Ning, William D Figg, William L Dahut

Clin Genitourin Cancer· August 2009

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Higher incidence of Osteonecrosis of the Jaw (ONJ) in patients with metastatic castration resistant prostate cancer treated with anti-angiogenic agents.
Jeanny B Aragon-Ching, Yang-Min Ning, Clara C Chen, Lea Latham, Jean-Pierre Guadagnini

Cancer Invest· February 2009

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